Assay Development Services

Primerdesign are experts in molecular diagnostic assay development. We have conducted many successful projects with leading diagnostic and biotechnology companies. Please contact us to enquire about how we can assist with the following services:

Assistance with regulatory approval of MDx assays including construction of the Design History File (DHF)

Primerdesign’s reagents and kits are manufactured to the highest standards within our ISO13485 quality management compliant facility. You can download our MDx development services brochures by clicking here.

Assay and Product Development

The Primerdesign team have a vast experience of molecular diagnostic test development. As well as developing hundreds of our own products, we are the engine for the development of novel molecular diagnostic tests and technologies for a number of other organisations. We can take your technology at any stage of the development process and add value by conducting the following services:

Prototype testing

Assay optimisation

Assay verification and validation (analytical and clinical)

Third party validation

Product Manufacture

We can manufacture your product ready for distribution. Our facilities are purpose built for molecular diagnostic kit assay development, dispensing and manufacturing. We provide:

SOPs, product handbooks and QC protocols

ISO13485 compliant manufacturing

Fully branded packaging or white label

Manufacturing (ISO13485 compliant)

Dispensing and lyophilisation (IVD kits)

Assistance with regulatory approval of MDx assays including construction of the Design History File (DHF)

New Test Development

We have a vast experience in new test development. We develop many hundreds of assays each year for a wide variety of applications. Every design project is led by a genuine expert from start to finish. We have an outstanding reputation with our clients for our expertise and excellent communication structures that we have in place. This ensures that project delivery is on time and on budget whilst our clients maintain complete visibility of the process.

Our areas of particular expertise include:

Infectious disease detection in humans

Pathogen detection in plants and animals

Companion diagnostic tests

SNP genotyping and rare mutation detection

Gene expression and assays

Water contamination tests

Food contamination tests

GMO detection

Meat speciation tests

Bio-threat detection

Genetic testing/gene modification

In 2009, Primerdesign created the first assay for H1N1 Swine Flu which resulted in media coverage. You can view the news report here.